The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TRN501 following a single administration of TRN501 or placebo to healthy adult male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, Japan
Safety evaluation of TRN501: Incidents of Treatment-Emergent Adverse Events
Name of adverse event, date and time of onset, severity, seriousness, outcome, date and time of outcome, and relationship to TRN501 of all adverse events (including serious adverse events) are evaluated.
Time frame: For each cohort, from the administration of investigational drug or placebo to 24 hours after the administration. If any adverse event(s) continue or occur after the end of the above time frame, follow-up will be conducted up to 4 weeks.
Safety evaluation of TRN501: Incidents of physical findings
The examination will include general findings and evaluation of the skin, eyes, ears/nose/throat, heart, chest, and abdomen. Record anything that is not normal, including those due to the subject's illness.
Time frame: 3 days and 2 nights (for each cohort)
Safety evaluation of TRN501: Vital sign (body temperature)
The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.
Time frame: 3 days and 2 nights (for each cohort)
Safety evaluation of TRN501: Vital sign (blood pressure)
The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Blood pressure is measured in sitting state.
Time frame: 3 days and 2 nights (for each cohort)
Safety evaluation of TRN501: Vital sign (pulse rate)
The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Pulse rate is measured in sitting state.
Time frame: 3 days and 2 nights (for each cohort)
Safety evaluation of TRN501: Columbia Suicide Severity Rating Scale (C-SSRS)
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Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
Each cohort consists of 9 participants and includes a placebo group. 6 in the TRN501 group and 3 in the placebo group, a total of 9 participants, are randomly assigned in a double-blind fashion. To each participant, single dose of TRN501 or a placebo will be administered.
To evaluate the safety and tolerability of TRN501, Columbia-Suicide Severity Rating Scale (C-SSRS) (Japanese version) is used to evaluates suicidal ideation and behavior. Scale range: Yes or No response to 11 questions, with minimum to maximum range of 0 to 5. Lower score represents better outcomes. Subscales not applicable.
Time frame: For each cohort, the day of entry (Day -1) and the day of leaving the facility (Day 2 or at the time of discontinuation).
Safety evaluation of TRN501: Incidents of participants with laboratory abnormality
The results of laboratory test values (hematological, blood biochemical, and urinary tests) will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.
Time frame: For each cohort, the day of entry (Day -1) and the day of leaving the facility (Day 2 or at the time of discontinuation).